FDA Device

Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.

Hazard

mislabeled as sterile

What You Should Do

Remedy

The recalling firm issued recall letters to their direct accounts via fax on 9/9/03. The letter informed the accounts of the problem and the need to sterilize the product or return it for replacements.

Products

Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
Brand
Vygon US LLC
UPC
Catalog number SP01, Lot numbers H0359, J0107, and J0493.

Units Affected

3 units